Balloon Sinus Dilation, also commonly referred to as Balloon Sinuplasty, is a minimally invasive technique that serves to gently open blocked sinus passageways with a thin, flexible balloon catheter. The technology was borrowed from our colleagues in cardiovascular medicine. In a similar manner, the same types of balloons that were utilized to open blocked heart arteries during a heart attack have now been adapted for use in sinus surgery. First introduced in 2004, the technology has undergone great scrutiny in regards to safety and effectiveness by the Ear, Nose and Throat community. Dr. Karanfilov was a contributor and co-author in the landmark study, which was published in 2007 in Otolaryngology – Head & Neck Surgery.
Balloon Sinus Surgery/Sinuplasty
The study was named CLEAR for Clinical Evaluation and Efficacy of Balloon Sinus Dilation. Chronic sinus sufferers were enrolled from several centers throughout the U.S. and Australia in 2005. 115 patients were followed for a minimum of 6 months after undergoing balloon sinus dilation. There were no complications or injuries to any patients enrolled in the study. Additionally, the study showed that the sinuses remained open in greater than 90% of cases.
Initially, Balloon Sinus Dilation required the use of a type of x-ray (fluoroscopy) to be able to see the balloon at the blocked sinus opening. Fortunately, the technology has evolved and now there are two nontraumatic options to follow proper placement of the balloon. In one system, a nontraumatic, flexible guidewire with a lighted tip is used to visualize proper placement of the balloon across the sinus opening. This has eliminated the need for fluoroscopy and made the procedure even safer for our patients. The most recent technology, adapted for balloon sinus dilation, is the use of computer image guidance(hyperlink to our description). In this situation, the balloon is guided into the blocked sinus passageway with the use of a navigation system for the sinuses. This has also eliminated the need for x-rays and has made the balloon more accessible in patients who have had previous surgery with closure or scarring of their sinus openings.
Dr. Karanfilov performed the first balloon sinus dilation in Ohio in 2005 and his first in-office balloon dilation under local anesthesia in 2007. In-office balloon sinus dilation utilizes the same tools and techniques as in the operating room, however, patients are now fully awake. Ohio Sinus Institute utilizes a procedure room, the latest endoscopic imaging technologies and computer image guidance for the most complicated cases. Dr. Karanfilov participated in the first clinical trial ORIOS I, which compared office balloon sinus dilation vs. traditional functional endoscopic sinus surgery (FESS) in the operating room. This study was published and showed that in-office balloon sinus dilation was safe, effective and well tolerated.
Dr. Karanfilov served as the senior principal investigator for the second in-office trial, ORIOS II. This study was the largest study to date evaluating the use of in-office balloon dilation. The title of the study is Office-Based Balloon Sinus Dilation: A prospective multi-center study of 203 patients. 203 patients were enrolled and underwent balloon dilation in the office setting under local anesthesia for medically refractory chronic sinusitis. The patients were followed out for 6 months after the procedure. The success of dilating a particular sinus was greater than 93%. Patients completed surveys and had cat scans and endoscopy to make certain the sinuses remained open. Surveys showed that patients achieved significant improvement in their sinus symptoms, cat scans confirmed this improvement and the great majority of patients felt the procedure to be very tolerable. There were no major complications.
Dr. Karanfilov’s most recent publication compared balloon sinus dilation to medical therapy for chronic sinusitis. The study was recently published and shows that balloon procedures are superior to medical treatment of refractory chronic sinusitis. Dr. Karanfilov is the most experienced balloon sinus expert in the area. He has published extensively and has been invited as an international lecturer and teacher of this technology. His invitations to speak have taken him to Russia, Spain, Bulgaria, Macedonia, Dubai and many locations in the U.S. He has performed live surgery during national ENT society meeting and has presented at various sinus courses. He has a wealth of knowledge, training, and research in this technology that is unmatched in Central Ohio.
Please visit our YouTube Channel video library to learn more about various office and operating room based nasal and sinus endoscopic procedures and surgeries.